CT-Angiography Versus Angiogram as Ancillary Tests in the Determination of Death by Neurologic Criteria

NCT07341490 | Recruiting

• 1 other identifier: 2025-4056
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnostic performance of a novel protocol for computed tomography-angiography, as ancillary test in the determination of complete cerebral infarction, in comparison to four vessel angiography.

Conditions

Infarction, Brain

Keywords

Cerebral infarction; Cerebral angiography; CT angiography; Brain Death; Diagnostic performance; Brain infarct

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance similar between computed tomography-angiography and four vessel angiography

  Sensitivity, specificity, positive predictive value, negative predictive value, inter- and intrarater variability.

  Periprocedural

Study Arms (1)

Suspected Complete Cerebral Infarction

Patients with severe acute brain injury, in whom complete cerebral infarction has been declared by direct neurological criteria, but ancillary testing is warranted due to specific circumstances.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving critical care

You may qualify if:

• Adults 18 years or older
• Ongoing critical care due to severe acute brain injury
• Four vessel angiography necessary for the determination of complete cerebral infarction, according to Swedish legislation

You may not qualify if:

• Treatment with extracorporeal membrane oxygenation (ECMO)
• Radiologic examination by computed tomography deemed too challenging due to respiratory or circulatory instability, as determined by responsible clinician

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Brain Infarction; Cerebral Infarction; Brain Death

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death

Central Study Contacts

Peter C Rudberg, M.D. Ph.D.

CONTACT

+46-8-1237000; peter.rudberg@ki.se

Anja Rosén, M.D.

CONTACT

+46-8-12370000; anja.rosen@ki.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D.

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)